The proposed guidance agenda lists topics such as opiate alkaloids in poppy seeds, food colors derived from natural sources ...

The Senate Parliamentarian reversed course on a small provision in the One Big Beautiful Bill Act that could boost cures for ...

A list of those FDA regulations and guidance documents under administration review is available on the Office of Management and Budget website.

The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants used to ...

On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that ...

Unicycive, which was seeking approval of oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease on dialysis, said the FDA issued a so-called complete response letter ...

Justice Department report reveals 2018 security breach allowed Sinaloa cartel to track FBI movements and target potential ...

The stunning new details offer a rare look at how technology can be exploited in the high-stakes battle between US law ...

The Substance Use Recovery Services Advisory Committee was created in 2021 to provide suggestions to lawmakers about substance use policy and treatment options.

The FDA didn’t routinely test the medications for quality problems or use its vast repository of drug-related complaints to proactively track whether they were harming the people who relied on them.

The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump ...